Medical and Scientific Aspects of Injuries - David B. Vermont Ashcraft & Gerel, LLP Alexandria, VA
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Medical and Scientific
Aspects of Injuries
David B. Vermont
Ashcraft & Gerel, LLP
Alexandria, VA
FDA News Release:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm1
49575.htm
23 reports of serious health problems ranging
from jaundice and elevated liver enzymes, an
indicator of potential liver injury, to liver
damage requiring liver transplant. One death
due to liver failure has been reported to the
FDA. Other health problems reported include
seizures; cardiovascular disorders; and
rhabdomyolysis, a type of muscle damage that
can lead to other serious health problems such
as kidney failure.
2
“The agency has not yet determined which
ingredients, dosages, or other health-related
factors may be associated with risks related to
these Hydroxycut products. The products
contain a variety of ingredients and herbal
extracts.”
3
1. Hydroxagen Plus®
2. HydroxyTea®
3. HydroxyCarb™
4. Hardcore™
5. Aqua Shed™
6. Hydroxycut Max™
4
Main Ingregients: Garcinia Cambogia, Gymnema Sylvestre,
phosphatidylserine-enriched soy lecithin,
and Rhodiola Rosea Extract
Variant Ingredients: Withania Somnifera, Glucomannan,
Alpha Liponic Acid and Soy Phospholipids
Products Contain Hydroxagen Plus:
- Hydroxycut Rapid Release Caplets (regular and caffeine free)
- Hydroxycut Ready To Drink Packets (regular and caffeine free)
- Hydroxycut Liquid Shots
- Hydroxycut Natural
- Hydroxycut 24
- Hydroxycut Carb Control
5
• Garcinia Cambogia - South Asian Fruit Tree
o High Content of Hydroxycitrate (HCA) : inhibits lipogenesis, lowers the production
of cholesterol and fatty acids, increases the production of glycogen in the liver,
suppresses appetite, increases the body's production of heat by activating the
process of thermogenesis
• Gymnema Sylvestre - Indian Climbing Plant (tropical forests)
o Increases Urine Output
• Phosphatidylserine Enriched Soy Lecithin
o Sometimes labels state Soy Phospholipids
o Source of choline; aids memory and cognitive function, cardiovascular health, liver
function, and physical and athletic performance.
• Rhodiola Rose Extract – Artic Flower
o Stimulates the immune system (stimulated immune cells)
o Mobilizes stored fat in the body
http://www.diet-and-health.net
http://www.soyconnection.com/soyfoods/pdf/SoyLecithinFactSheet3.pdf
http://www.anti-aging-drugs.com/rhodiola.htm
6
• Withania Somnifera – Indian Flowering Plant
o Increases Urine Volume
o Products: Hydroxycut 24 and Hydroxycut Natural
• Glucomannan – Soluable Fiber
o Lowers blood sugar and cholesterol
o Promoted weight gloss
o Hydroxycut Carb Control
Alpha Lipoic Acid – Water and Fat Soluable Antioxidant
o Promotes energy formation
o Hydroxycut Carb Control
http://www.healthline.com/natstandardcontent/ashwagandha-1
http://www.drugs.com/npp/glucomannan.html
7
Main Ingregients: Green Tea Extract, Caffeine Anhydrous, White Tea
Extract, and Oolong Tea Extract
Variant Ingredients: Guarana Extract/Powder, Ginger Extract,
Raspberry Ketones, and Quercetin Dihydrate
Products Contain HydroxyTea:
- Hydroxycut Rapid Release Caplets (regular and caffeine free)
- Hydroxycut Ready To Drink Packets (regular and caffeine free)
- Hydroxycut Liquid Shots
- Hydroxycut Natural
- Hydroxycut 24
- Hydroxycut Carb Control
8
• Camellia Sinensis – Tea Plant
Note: Green Tea Extract, White Tea Extract,
and Oolong Tea Extract are all products of this plant.
o Green Tea Extract- increases the body's thermogenesis,
the generation of body heat, burns the calories and fat
needed to lose weight; lowers LDL cholesterol; and
boosts immune system
o White Tea Extract - increases the body's metabolism to
help you lose weight and acts as a diuretic
o Oolong tea Extract - productive in fat burning; boosts
metabolism and the immune system
•Caffeine Anhydrous – general caffeine without
water
http://www.herbal-supplements-guide.com/green-tea-benefits.html
http://www.whitetea.com/benefits-of-white-tea.php
http://hubpages.com/hub/All-About-Oolong
9•Guarana Extract/Powder – Amazon climbing plant
o effective energy booster
o contains about twice the caffeine found in coffee beans
•Ginger Extract - stem of ginger plant
o increase the motility of the gastrointestinal tract
•Raspberry Ketones – aroma compound in red raspberries
o prevents high-fat-diet-induced elevations in body weight
o alters lipid metabolism
•Quercetin dihydrate – naturall occuring bioflavonoid
o Antioxidant
o Research indicates numerous benefits (cardiovascular, allgeries, cataracts, diabetes), but none
directly related to weight loss.
http://en.wikipedia.org/wiki/Guarana
http://en.wikipedia.org/wiki/Ginger
http://en.wikipedia.org/wiki/Raspberry_ketone
http://www.zhion.com/phytonutrients/Quercetin.html
10• Gymnema Sylvestre Extract – same ingredient is in Hydroxagen Plus Blend
(increases urine output)
•Xanthan Gum
o Thickening agent and stabilizer
o Used in dairy products and salad dressing
• Cinnamomum Verum Extract – Bark of Sri Lankan Evergreen
o Cinnamon Tree Bark
o warms and stimulates the digestive system
o oil may help break down fats during digestion
• Banaba Extract – Philippine Crepe Myrtle
o Keeps blood sugar and insulin levels in check, thus may be an effective supplement
for promoting weight
o Researchers theorize that modulation of glucose and insulin levels reduces total
caloric intake somewhat and encourages moderate weight loss.
Griffonia Simplicifolia Extract - African woody climbing shrub
o Used for it 5-Hydroxytryptophan (5-HTP) content.
o 5-HTP is an important building block for the human body to form serotonin.
o (Serotonin acts both as a chemical messenger that transmits nerve signals between nerve cells and that causes
blood vessels to narrow).
http://en.wikipedia.org/wiki/Xanthan
http://www.smart-publications.com/weight_loss/banaba_extract.php
http://en.wikipedia.org/wiki/Griffonia_simplicifolia
11•Combination of Four Other Blends:
o Pyroxyclene™ Fat Loss Blend
o Norepidrol Intensity Focus Blend
o Lesidrate Delivery Blend
o Yohimbaore Blend
• Products Containing the Hardcore Blend:
o Hardcore Liquid Caplets
o Ignition Stix
12•Contains Three Other Blends:
o QuickShed
o AntiOx Enhance
o RevitaFemme
•Max Aqua Shed – only product using this blend.
13• Contain Two Other Blends:
o Max! LiquiBurn Blend
o Max! Weight-Loss Matrix
•Products Containing This Blend:
o Max Liquid Caplets
o Max Drink Packets
14• The FDA was uncertain which ingredients, or combination of
ingredients, was specifically to blame for the increased liver
injury risks.
•The common ingredient to all recalled Hydroxycut products
and proprietary blends is Green Tea Extract; with the second
most common being Garcinia Cambogia.
• No product label states the exact amount of Garcinia
Cambogia or Green Tea Extract used in that product and not all
bottles even have a product label.
•At this time, it is unclear whether the culprit ingredient is one
of these individual ingredients, or the combination of the two,
or the combination of either one with some other ingredient.
15 The liver helps purify the blood by changing
potentially harmful chemicals into harmless ones. The
sources of the harmful chemicals can be from outside
the body (for example, medications or alcohol), or
inside the body (for example, ammonia,).
The liver removes chemicals from the blood and then
either secretes them with the bile for elimination in the
stool, or secretes them back into the blood where they
then are removed by the kidneys and eliminated in the
urine.
The liver produces many important substances,
especially proteins that are necessary for good health.
For example, it produces albumin, the protein
building-block of the body.
16 Proteins, specific to the liver, combine with the
potentially harmful chemicals to break them apart and
make them inert.
The main enzymes that perform this task are:
Aspartate Aamino Transferase (AST) and Alanine
Amino Transferase (ALT). They are highly specific to
the liver.
Toxins that are harmful to the liver kill the liver cell.
ALT and AST leak out into the blood stream.
A doctor can then test you blood for the presence of
these liver enzymes. At any given time every person
will have a “normal” level of ALT and AST in the
blood stream.
17 Normal level of AST and ALT varies from lab to lab,
each lab using a slightly different scale. The labs
normal will be listed with the lab results. Generally, is
between 35 and 50 (u/l)(units per liter).
Doctors to not become concerned about enzyme
elevations until they exceed 3xULN.
Other liver tests include Alkaline Phosphatase (less
specific to the liver), Total Billirubin (indicates
involvement of the bile ducts and possibly advanced
disease) and Albumin (necessary chemical produced
by the liver – low amounts indicate the liver is not
functioning well).
18 Acute drug-induced hepatitis is much more common than chronic drug-induced
hepatitis by a ratio of 9:1.
Typical symptoms of drug-induced hepatitis include:
loss of appetite, nausea, vomiting,
fever, weakness, tiredness, and
abdominal pain.
In more serious cases, patients can develop dark urine, fever, light-colored stool,
and jaundice (a yellow appearance to the skin and white portion of the eyes).
The main treatment is cessation of the offending drug.
The liver has the ability to heal itself and the proving permanent damage is
difficult.
Ultrasounds can be used to diagnosis some degree of permanent damage but is
relatively unspecific. Only liver biopsy can 100% confirm permanent liver damage.
However, the onset of Jaundice is generally sufficient to infer permanent
impairment of the liver.
19 Finally, the key to establishing Drug Induced
Liver Disease is to rule out potential other
causes.
Challenge and de-challenge.
Alcohol
Fatty liver: particularly in diabetics.
viral hepatitis B and hepatitis C (tattoos).
exclude chronic liver diseases such as autoimmune
hepatitis (look for other autoimmune disorders like
Lupus or Rheumatoid arthritis) and primary biliary
cirrhosis (PBC)(inflammation and destruction of the
small bile ducts).
20 Rhabdomyolysis: is the rapid destruction of
skeletal muscle resulting in leakage into the
urine of the muscle protein myoglobin.
Primarily diagnosed by elevated Creatine
Phosphokinase (CPK) levels in blood.
The most common & serious complication of
rhabdomyolysis is kidney failure.
This can occur for a variety of reasons. Direct injury to
the kidney and plugging of the filtering tubes of the
kidneys by the muscle proteins are among the causes of
kidney function impairment in the setting of
rhabdomyolysis.
21 Eliminate other potential causes of “Rabdo”:
Severe trauma to muscles
Cocaine
STATINS: Lipitor, Crestor, Zocor, Pravachol, etc
Hypothyroidism
Snake bites!
22 Seizures and Cardiovascular disorders:
FDA reports are very non-specific in this area.
What we do know is that users of Hydroxycut report
racing heart beats, palpations, etc.
This could be for any number of reasons including, but
not limited to:
Use of caffeine in Hydroxycut.
The products overall effect to increase metabolic rate.
Some of the ingredients have an effect of cholesterol levels.
Some of the ingredients could effect electrical signals in the
heart or blood vessels.
23David B. Vermont
Ashcraft & Gerel, LLP
4900 Seminary Road, Suite 650
Alexandria, VA 22311
Direct Dial: 703-824-4776
Main: 703-931-5500
Fax: 703-820-1656
www.ashcraftandgerel.com
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